DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/12/25 has been entered.
Claim Objections
Claim 21 is objected to because of the following informalities: line 1 should be amended to -The wearable [[drug]] therapeutic agent delivery device of claim 7, further comprising a controller communicatively coupled to the power source-. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
The following claim limitations
A resilient sealing member (claims 1, 12 and 17)
A second resilient sealing member (claims 1, 12 and 17)
Switching device (claims 1, 12 and 17)
Biasing device (claims 5 and 16)
has/have been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses/they use a generic placeholder
Member (A resilient sealing member - claims 1, 12 and 17)
Member (A second resilient sealing member - claims 1, 12 and 17)
Device (Switching device - claims 1, 12 and 17)
Device (Biasing device - claims 5 and 16)
coupled with functional language
Sealing the pump chamber (A resilient sealing member - claims 1, 12 and 17)
Is operable to seal the inlet channel and the outlet channel (A second resilient sealing member - claims 1, 12 and 17)
The switching device biases the second resilient sealing member against an entrance of the inlet channel… (Switching device - claims 1, 12 and 17)
Causes the follower to move relative to the housing (Biasing device - claims 5 and 16)
without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier.
Since the claim limitation(s) invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, claim(s) 1, 2, 3, 5, 12, 13, 16, 17 and 20 has/have been interpreted to cover the corresponding structure described in the specification that achieves the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
Gasket (¶0018) (A resilient sealing member - claims 1, 12 and 17)
Gasket (¶0018) (A second resilient sealing member - claims 2, 13 and 20)
Mechanical toggle (¶0037) (Switching device - claim 3)
SMA wire, motor, linear actuator, spring (¶0038) (Biasing device - 1, 12 and 17)
If applicant wishes to provide further explanation or dispute the examiner’s interpretation of the corresponding structure, applicant must identify the corresponding structure with reference to the specification by page and line number, and to the drawing, if any, by reference characters in response to this Office action.
If applicant does not intend to have the claim limitation(s) treated under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112 , sixth paragraph, applicant may amend the claim(s) so that it/they will clearly not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, or present a sufficient showing that the claim recites/recite sufficient structure, material, or acts for performing the claimed function to preclude application of 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
For more information, see MPEP § 2173 et seq. and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 15 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 15:
The claim recites the limitation "mechanical rocker device" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Also, the claim is unclear because of the “mechanical rocker device” in line 3. This limitation is unclear since it seems to overlap with the “switching device” of claim 12 however it is claimed as if it is a separate structure. For the sake of examination, the office has assumed that the switching device includes the mechanical rocker.
Regarding claim 17:
The claim limitation “biasing the plunger into the pump chamber to displace the liquid therapeutic agent from the pump chamber” in the final line of the claim is unclear. It’s unclear if this limitation should also be removed from the claim or included. The previous line includes a period at the end making it unclear if this was intended to be removed or kept. For the sake of examination, the office has assumed that it was intended for this limitation to be included in the claim.
Regarding claim 20:
The claim limitation “a second resilient sealing member” in line 2 is unclear. The limitation is unclear because of the earlier recitation of the limitation “a second resilient sealing member” in line 14 of claim 17 (on which this claim depends) which raises a question of if two of second resilient sealing members are required by the claim 20 or only one. For the sake of examination, the office has assumed that only one second resilient sealing member is required by the claim.
The same clarity issues exist for the limitations “a first position” (line 3), “an entrance” (line 5), “a second position” (line 5) and “an entrance” (line 6). These limitations are also established in claim 17 raising similar issues as established above. For the sake of examination, the office has taken the same interpretation as indicated above.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 4, 5, 9-12 and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 4277226 A to Archibald.
Archibald discloses:
Regarding claim 1:
A wearable therapeutic agent delivery device (figure 1), comprising:
a reservoir (12) configured to store a liquid therapeutic agent (“IV fluid”, column 3, lines 15-20);
a delivery pump device (10) including a drive mechanism (28/32) coupled to the reservoir (12) for receiving the liquid therapeutic agent (“IV fluid”), the drive mechanism (28/32) comprising:
a housing (28) comprising:
a pump chamber (36) fluidly connected with a channel chamber (see the channel chamber A in figure 1 below);
an inlet channel (see channel C in figure 1 below) operable to deliver the liquid therapeutic agent (“IV fluid”) from the reservoir (12) to the channel chamber (34) (inlet channel C supplies fluid to the channel chamber 34 as shown in figure 1 below; column 3, lines 45-56);
an outlet channel (see outlet channel D in figure 1 below) operable to expel the liquid therapeutic agent (“IV fluid”) from the channel chamber (34) (34 is the outlet for the chamber 34; column 3, line 65- column 4, line 15);
a resilient sealing member (portion of diaphragm (element B in figure 1 below) within 30 in the pump chamber 36) sealing the pump chamber (36); and
a plunger (48) operable to enter the pump chamber (36) to displace the liquid therapeutic agent (“IV fluid”) from the pump chamber (34/36) (column 5, lines 50-68);
a second resilient sealing member (portion of diaphragm within 30 in the channel C and D (in figure 1 below) and chamber 34) positioned within the channel chamber (34), wherein the second resilient sealing member is operable to seal (seals C and D via the valves 51a and 51b) the inlet channel (C in figure 1 below) and the outlet channel (D in figure 1 below); and
a switching device (51a, 51b, 62, 68, 60; consistent with the 112(f) interpretation of a toggle since it actuates the valves 51a/51b back and forth), wherein in a first position (position in which valve 51a is in the closed position) the switching device biases the second resilient sealing member against an entrance of the inlet channel (when valve 51a is in the closed position the second resilient sealing member/diaphragm within the channel C is closed or compressed), and wherein in a second position (position in which valve 51b is in the closed position) the switching device biases the second resilient sealing member against an entrance of the outlet channel (when valve 51b is in the closed position the second resilient sealing member/diaphragm within the channel D is closed or compressed)(column 5, lines 35-45).
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Figure 1 – figure of Archibald, annotated by the examiner
Regarding claim 4:
The wearable therapeutic agent delivery device of claim 1, further comprising a follower (70/52/72/74/76) coupled to the switching device (51a/51c), wherein movement of the follower relative to the housing (28) causes the switching device to move (rods 70/52 allows for the valves 51a and 51c to move into the first or second positions) between the first and second positions (closed positions of 51a and 51c).
Regarding claim 5:
The wearable therapeutic agent delivery device of claim 4, further comprising a vising device (78 or actuator 64) coupled to the follower (70/52/72/74/76), wherein the biasing device (78 or actuator 64) causes the follower to move (results in the follower moving into different positions) relative to the housing (28).
Regarding claim 9:
The wearable therapeutic agent delivery device of claim 5, further comprising a return spring (78) coupled to the follower (70/52), wherein the biasing device (actuator 64) causes the follower (70/52) to move in a first direction (direction towards the housing 28), and wherein the return spring (78) causes the follower (70/52) to move in a second direction (causes the follower to move towards the shaft 60), opposite the first direction.
Regarding claim 10:
The wearable therapeutic agent delivery device of claim 5, further comprising a plunger spring (100) in abutment (spring contacts follower 75 and plunger 46) with the plunger (46/48) and with the follower (70/52/72/74/76), wherein the plunger spring (100) is operable to cause the plunger to enter (spring 100 applies a force to plunger 46 pushing it into chamber 34) the pump chamber (34) as the follower (70/52/72/74/76) moves towards (force applied as the follower as it moves toward 28) the housing (28).
Regarding claim 11:
The wearable therapeutic agent delivery device of claim 1, wherein the plunger (48) is positioned within a plunger chamber (36) , and wherein the resilient sealing member (diaphragm of diaphragm chamber 30 in chambers 36) is positioned between the plunger chamber and the pump chamber (36).
Regarding claim 12:
A drive mechanism (28/32) of a wearable drug delivery device, the drive mechanism (28/32) comprising:
a housing (28) comprising:
a pump chamber fluidly connected with a channel chamber;
an inlet channel (20) operable to deliver a liquid therapeutic agent (“IV fluid”) from a reservoir (12) to the channel chamber (see the channel chamber A in figure 1 above) (inlet channel 20 supplies fluid to the channel chamber A as shown in figure 1 below; column 3, lines 45-56); and
an outlet channel (24) operable to expel the liquid therapeutic agent (“IV fluid”) from the channel chamber (see the channel chamber A in figure 1 above) (24 is the outlet for the chamber A; column 3, line 65- column 4, line 15);
a resilient sealing member (portion of diaphragm (element B in figure 1 above) within 30 in the pump chamber 36) sealing pump chamber (36); and
a plunger (48) operable to enter the pump chamber (36) to displace the liquid therapeutic agent (“IV fluid”) from the pump chamber (36) (column 5, lines 50-68);
a second resilient sealing member (portion of diaphragm within 30 in the channel C and D (in figure 1 above) and chamber 34) positioned within the channel chamber (34), wherein the second resilient sealing member is operable to seal (seals C and D via the valves 51a and 51b) the inlet channel (C in figure 1 below) and the outlet channel (D in figure 1 below); and
a switching device (51a, 51b, 62, 68, 60; consistent with the 112(f) interpretation of a toggle since it actuates the valves 51a/51b back and forth), wherein in a first position (position in which valve 51a is in the closed position) the switching device biases the second resilient sealing member against an entrance of the inlet channel (when valve 51a is in the closed position the second resilient sealing member/diaphragm within the channel C is closed or compressed), and wherein in a second position (position in which valve 51b is in the closed position) the switching device biases the second resilient sealing member against and entrance of the outlet channel (when valve 51b is in the closed position the second resilient sealing member/diaphragm within the channel D is closed or compressed)(column 5, lines 35-45).
Regarding claim 17:
A method, comprising:
coupling (coupled via tubing 16) a drive mechanism (28/32) to a reservoir (12) configured to store a liquid therapeutic agent (“IV fluid”), the drive mechanism (28/32) comprising:
a housing (28) comprising:
a pump chamber (34/36) fluidly connected with a channel chamber (see the channel chamber A in figure 1 above);
an inlet channel (20) operable to deliver the liquid therapeutic agent (“IV fluid”) from the reservoir (12) to the channel chamber (see the channel chamber A in figure 1 above) (inlet channel 20 supplies fluid to the channel chamber A as shown in figure 1 below; column 3, lines 45-56); and
an outlet channel (24) operable to expel the liquid therapeutic agent (“IV fluid”) from the channel chamber (see the channel chamber A in figure 1 above) (24 is the outlet for the chamber A; column 3, line 65- column 4, line 15);
a resilient sealing member (portion of diaphragm (element B in figure 1 above) within 30 in the pump chamber 36) sealing the pump chamber (36); and
a plunger (48) operable to enter the pump chamber (36) to displace (column 5, lines 50-68) the liquid therapeutic agent (“IV fluid”) from the pump chamber (36);
a second resilient sealing member (portion of diaphragm within 30 in the channel C and D (in figure 1 above) and chamber 34) positioned within the channel chamber (34), wherein the second resilient sealing member is operable to seal (seals C and D via the valves 51a and 51b) the inlet channel (C in figure 1 below) and the outlet channel (D in figure 1 below); and
a switching device (51a, 51b, 62, 68, 60; consistent with the 112(f) interpretation of a toggle since it actuates the valves 51a/51b back and forth), wherein in a first position (position in which valve 51a is in the closed position) the switching device biases the second resilient sealing member against an entrance of the inlet channel (when valve 51a is in the closed position the second resilient sealing member/diaphragm within the channel C is closed or compressed), and wherein in a second position (position in which valve 51b is in the closed position) the switching device biases the second resilient sealing member against an entrance of the outlet channel (when valve 51b is in the closed position the second resilient sealing member/diaphragm within the channel D is closed or compressed)(column 5, lines 35-45);
biasing (biased via spring 100) the plunger (48) into the pump chamber (36) to displace the liquid therapeutic agent (“IV fluid”) from the pump chamber (36).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 6, 7, 15 and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 4277226 A to Archibald as applied to claims 5, 13 and 17 above, and further in view of WO 2004032994 A2 to Rush et al. (Rush).
Regarding claim 6:
Archibald fails to disclose:
The wearable therapeutic agent delivery device of claim 5, wherein the biasing device is a shape memory alloy wire.
Rush teaches:
A fluid delivery device (figure 1B) that includes a plunger and follower (112) that is connected to a rod (119) that is actuated by and spring (15) and SMA wire/biasing device (114). Further, the SMA wire is controlled by a power source (118).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Archibald to replace the biasing device (64 in Archibald) with a SMA wire/biasing device and rod (further including the power source 118) as taught by Rush in order to actuate follower/rod in Archibald. This would be a simple substitution of one known element (biasing device as taught by Archibald) for another (biasing device/SMA wire and rod as taught by Rush) to obtain predictable results (to actuate the plunger in Archibald). The SMA wire/biasing device would be further controlled by the power source 118 in Rush.
Regarding claim 7:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 6 by Archibald and Rush:
The wearable therapeutic agent delivery device of claim 6, further comprising further comprising a power source (see the power source of Rush incorporated into Archibald as part of the SMA wire/biasing device) coupled to the shape memory alloy wire (see the SMA wire of Rush incorporated into Archibald), wherein power from the power source causes the shape memory alloy wire to contract (see the power device of Rush (¶0026) incorporated into Archibald).
Regarding claim 15:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 14 by Archibald and Rush:
The drive mechanism of claim 12, further comprising:
a follower (70/52 of Archibald) coupled to the mechanical rocker device (see the mechanical rocker device 119 of Rush incorporated into Archibald that actuates the follower 70/52), wherein movement of the follower (70/52 of Archibald) relative to the housing (28 of Archibald) causes the mechanical rocker device to move between the first and second positions (the movement of the mechanical rocker device 119 of Rush in Archibald moves form a first and second position to actuate the follower 70/52 and open or close the valves); and
a shape memory alloy wire (see the shape memory alloy wire 114 of Rush incorporated into Archibald) coupled to the follower (coupled to the follower 70/52 of Archibald via the mechanical rocker device 119 of Rush incorporated into Archibald), wherein the shape memory alloy wire causes the follower to move relative to the housing (the movement of the SMA wire 114 of Rush actuates the mechanical rocker device which actuates the follower 70/52).
Regarding claim 16:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 14 by Archibald and Rush:
The drive mechanism of claim 15, further comprising a return spring (see the return spring 115 of Rush incorporated into Archibald) coupled to the follower (70/52 of Archibald), wherein the biasing device (see the SMA wire of Rush incorporated into Archibald) causes the follower (70/52 of Archibald) to move in a first direction (SMA wire actuates the rocker 119 of rush and valve 51a/51c (of Archibald) in a first direction), and wherein the return spring (the return spring 115 of Rush actuates the rocker 119 in the second or opposite direction) causes the follower (70/52 of Archibald) to move in a second direction, opposite the first direction.
Regarding claim 18:
Archibald discloses:
The method of claim 17, further comprising:
coupling the plunger (46/48 or 51a/51c) to a follower (72/76 or 70/52).
Archibald fails to disclose:
Coupling a shape memory alloy wire to the follower, wherein biasing the plunger comprises activating the shape memory alloy wire to bias the follower and the plunger towards the housing.
Rush teaches:
A fluid delivery device (figure 1B) that includes a plunger and follower (112) that is connected to a rod/mechanical rocker device (119) that is actuated by and spring (15) and SMA wire/biasing device (114). Further, the SMA wire is controlled by a power source (118).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Archibald to replace the biasing device (64 in Archibald) with a SMA wire/spring/biasing device and rod/mechanical rocker device (further including the power source 118) for each follower/rod (72/76 or 70/52 of Archibald) as taught by Rush in order to actuate follower/rod in Archibald. This would be a simple substitution of one known element (biasing device 62 as taught by Archibald) for another (biasing device/SMA wire and rod as taught by Rush) to obtain predictable results (to actuate each plunger 46/48 or 51a/51c in Archibald). The SMA wire/spring/biasing device would be further controlled by the power source 118 in Rush.
Regarding claim 19:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 14 by Archibald and Rush:
The method of claim 18, further comprising de-activating the shape memory alloy wire to bias the follower and the plunger away from the housing (the shape memory alloy wire of Rush would actuate the follower 72/76 and plunger 46/48 of Archibald when deactivated by the controller/power source 118 when incorporated into Archibald), wherein biasing the plunger away from the housing causes the liquid therapeutic agent to enter the pump chamber through the inlet channel (the shape memory alloy wire of Rush would actuate the follower 72/76 and plunger 46/48 of Archibald when activated by the controller/power source 118 when incorporated into Archibald).
Regarding claim 20:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 14 by Archibald and Rush:
The method of claim 18, further comprising:
positioning a second resilient sealing member (diaphragm of diaphragm chamber 30 in chambers above valve 51a in Archibald) within the channel chamber(see the channel chamber A in figure 1 above in Archibald);
coupling a mechanical rocker device (see the mechanical rocker device 119 of Rush incorporated into Archibald) to the follower (70 of Archibald), wherein in a first position the mechanical rocker device biases (the mechanical rocker device actuates of rush the follower 70 of Archibald against the valves 51a to close the inlet 20) the second resilient sealing member (diaphragm of diaphragm chamber 30 in chambers above valve 51a in Archibald) against an entrance of the inlet channel (20 of Archibald), and wherein in a second position the mechanical rocker device biases the second resilient sealing member against an entrance of the outlet channel; and
biasing the follower (52 of Archibald) relative to the housing to cause the mechanical rocker device (see the mechanical rocker device 119 of Rush incorporated into Archibald) to transition between the first position and the second position (the mechanical rocker device actuates of Rush the follower 52 of Archibald against the valves 51c to close the outlet 24).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 4277226 A to Archibald and WO 2004032994 A2 to Rush et al. (Rush) as applied to claim 7 above, and further in view of US 20070191716 A1 to Goldberger et al. (Goldberger).
Regarding claim 21:
Archibald discloses:
The wearable drug delivery device of claim 7, further comprising a controller (58) communicatively coupled to the power source (inherent since controller includes or is coupled to a power source to power 56 and 86) , wherein the controller is operable to:
receive an input indicating an automated delivery application setting (see column 5, lines 19-35 which indicates how the controller 58 receives a signal to allow the motor to continue and not shut down the pump); and
in response to the input, activate the power source (with the signal the controller uses the power source to activate or run the motor/ actuator 56).
Archibald and Rush fail to disclose:
receive an input indicating an automated insulin delivery (AID) application setting.
Goldberger teaches:
A pump system (figure 1a) that uses IV fluids (9) supplied to a patient (2). The system further teaches the IV fluid can be insulin (¶0136).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Archibald and Rush to make the IV fluid in Archibald an insulin as taught by Goldberger to control the amount of insulin in the patient’s blood stream (¶0136). Making the IV fluid in Archibald insulin results in the signal supplied to the controller that the IV bag is empty an automated insulin delivery (AID) application setting since the signal would now be indicative of the amount of insulin within the IV bag.
Response to Arguments
Applicant's arguments filed 11/12/25 have been fully considered but they are not persuasive.
Regarding the 35 USC 102 and 103 claim rejections:
The applicant’s amendments to the claims resulted in a modification of the previous rejection to read on the claims. While the applicant is correct that the previous rejection by Archibald would not have read on the claim the modified rejection above now reads on the amended claims and for this reason the rejection by Archibald is maintained. The applicant provides several arguments as to why the previous rejection did not read on the claims (see pages 11-13 of the remarks) and the office would agree with this argument. However, with the new rejection the structure of the second resilient sealing member has been interpreted as element A in figure 1 above and the resilient sealing member has been interpreted as element B in figure 1 above. With this new interpretation (as indicated above), the new rejection reads on the limitations of the claims and the above rejection is maintained.
Regarding the claim objections:
The applicant’s amendments to the claims have addressed the previous claim objections and for this reason they are withdrawn. However, a new set of objections have been made above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WESLEY HARRIS whose telephone number is (571)272-3665. The examiner can normally be reached M to F, 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WESLEY G HARRIS/Examiner, Art Unit 3783